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Ensifentrine

Ensifentrine · ENSIFENTRINE 1 kg/kg · Powder · Inke SA

NDC 64567-0033-00 · 5 kg in 1 DRUM · BULK INGREDIENT · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (bulk ingredient) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $2,836.06 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Ensifentrine (Powder)

LabelerStrengthFirst seenLast seen
Hovione Farmaciencia SaENSIFENTRINE 1 kg/kgJul 15, 2026Sep 2, 2026
Inke SAENSIFENTRINE 1 kg/kgJul 15, 2026Sep 2, 2026
MSN Life Sciences Private LimitedENSIFENTRINE 1 kg/kgJul 15, 2026Sep 2, 2026
Sterling SpaENSIFENTRINE 1 kg/kgJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Ensifentrine — NDC 64567-0033-00," retrieved September 3, 2026, https://drugdashboards.com/drug/64567003300.

Free to cite with attribution — see how the data is put together.